USDM Life Sciences

USDM Life Sciences USDM Life Sciences helps life sciences companies navigate compliance, quality, and digital transformation with confidence. We see farther.

From validation and data integrity to AI governance and cybersecurity, we help regulated teams move faster and smarter. Our purpose is to bring clarity and action to the interplay of technology and regulations.For more than two decades, we have exclusively tackled challenges in the life sciences. These companies are challenged because the very core of their work is about human existence – improvin

g and extending life itself. We make digital transformation in highly regulated areas possible, even simple, and everyone wins – especially the patient.Our people make the difference. We are driven by our passion for creating transformative progress to accelerate live-savings medicines and therapies. We are subject matter experts that have walked in your shoes and understand the nuances of your business challenges.

When a hyper-growth biotech was managing 3 concurrent missing-document logs across multiple CROs — with turnaround somet...
06/17/2026

When a hyper-growth biotech was managing 3 concurrent missing-document logs across multiple CROs — with turnaround sometimes hitting 3 months — TMF completeness had become a liability.

USDM consolidated everything into Veeva Vault: one governed system of record, real-time cycle time visibility, and inspection-ready traceability at scale.

See how we did it:

Case study: See how USDM Life Sciences replaced three disconnected eTMF spreadsheet logs with unified Veeva Vault workflows for a hyper-growth biotech — delivering real-time TMF completeness, multi-CRO accountability, and inspection-ready oversight.

Scaling AI in life sciences isn't a technology problem. It's a compliance and validation problem.Leaders from Google, Fe...
06/17/2026

Scaling AI in life sciences isn't a technology problem. It's a compliance and validation problem.

Leaders from Google, Fenwick & West, and USDM break down how to operationalize compliant AI at the USDM Life Sciences Summit 2026.

Watch it here →

How do you scale AI in a regulated environment without increasing c...

A global life sciences leader came to USDM with a familiar problem: document-heavy validation workflows, a CMDB full of ...
06/16/2026

A global life sciences leader came to USDM with a familiar problem: document-heavy validation workflows, a CMDB full of inconsistent records, and manual handoffs that were slowing compliance and audit readiness.
By deploying ProcessX on ServiceNow, the results speak for themselves:

✅ 75% reduction in compliance cycle time
✅ CMDB data reliability improved from 62% → 94%
✅ 4,200 redundant records eliminated
✅ Audit reports that once took 3 weeks now generate instantly

Regulated ITSM doesn't have to be a bottleneck. Read the full case study:

Case study: See how a global life sciences organization used ProcessX on ServiceNow to reduce regulated ITSM compliance cycle time by 75%, improve CMDB data reliability by 85%, and eliminate 4,200 redundant records.

Glean brings enterprise search, AI answers, and agents into one Work AI platform.USDM brings the GxP validation, governa...
06/16/2026

Glean brings enterprise search, AI answers, and agents into one Work AI platform.

USDM brings the GxP validation, governance, and life sciences expertise to make it inspection-ready.
Together, we turn fragmented enterprise knowledge into governed, permission-aware AI — built for regulated teams.

Learn more:

Glean Work AI paired with USDM GxP validation, governance, connectors, agents, inspection readiness, and adoption services for regulated life sciences teams.

Is your product information ready for the future of regulatory exchange?HL7 FHIR and electronic product information (ePI...
06/15/2026

Is your product information ready for the future of regulatory exchange?

HL7 FHIR and electronic product information (ePI) are reshaping how medicinal product data moves across systems, regions, and use cases. But FHIR isn't a silver bullet — structured product information only delivers on its promise when the underlying data is governed, validated, and traceable.

Learn why readiness for ePI is a cross-functional challenge — spanning Regulatory, Quality, IT, Data, and Commercial teams — and what it takes to build the operating model behind structured medicinal product information.

Blog post: Why HL7 FHIR-based electronic product information requires more than data mapping, and how life sciences teams can prepare the governance, validation, and operating model behind structured medicinal product information.

Third-party risk reviews should move faster, but the risk decision still belongs to people.USDM’s Cybersecurity & TPRM a...
06/15/2026

Third-party risk reviews should move faster, but the risk decision still belongs to people.

USDM’s Cybersecurity & TPRM agentic workflow shows how governed AI can help life sciences teams collect evidence, map controls, flag gaps, and prepare vendor review packets while security, legal, privacy, procurement, and business owners stay accountable.

Useful automation. Human-owned decisions.

The only partner that governs AI AND builds it within GxP guardrails.

AI governance in life sciences is no longer a policy exercise.It is an operating model issue: intended use, risk classif...
06/12/2026

AI governance in life sciences is no longer a policy exercise.

It is an operating model issue: intended use, risk classification, validation planning, vendor oversight, data controls, lifecycle monitoring, change control, and evidence that can stand up to audit or inspection.

USDM’s 37-page white paper lays out an enterprise framework for compliant, scalable AI adoption across GxP environments, including EU AI Act readiness, FDA CSA, GAMP 5, ISO 42001-aligned practices, partner AI risk, and a practical 90-day pathway to a governance baseline.

Download the white paper: https://lnkd.in/gJg7ea48

White paper: Download USDM's AI governance for life sciences white paper for an enterprise framework covering GxP AI governance, vendor risk, lifecycle controls, and compliant AI adoption.

06/12/2026

AI is already changing how life sciences teams operate—from quality and regulatory to clinical and manufacturing. The hard part isn't whether to use it. It's how to deploy it without compromising compliance.

USDM Life Sciences' new white paper breaks down 47 real-world AI use cases and the validation frameworks behind them.

Download it here → https://usdm.com/resources/white-papers/ai-use-case-dossier

The question is not “Glean versus the rest of the stack.” It is: where does Glean fit so the rest of the enterprise AI s...
06/11/2026

The question is not “Glean versus the rest of the stack.” It is: where does Glean fit so the rest of the enterprise AI stack becomes more usable, governed, and connected?

For life sciences companies, that distinction matters. AI has to respect approved sources, access rights, auditability, human review, and the way regulated teams actually work across quality, regulatory, clinical, manufacturing, safety, medical, commercial, IT, and corporate functions.

USDM breaks down Glean’s role in the enterprise AI ecosystem:

Blog post: A practical look at how Glean fits into the enterprise AI ecosystem as a governed work AI layer across knowledge, permissions, assistants, agents, and workflows.

Address

535 Chapala Street
Santa Barbara, CA
93101

Opening Hours

Monday 9am - 5pm
Tuesday 9am - 5pm
Wednesday 9am - 5pm
Thursday 9am - 5pm
Friday 9am - 5pm

Telephone

+18882310816

Alerts

Be the first to know and let us send you an email when USDM Life Sciences posts news and promotions. Your email address will not be used for any other purpose, and you can unsubscribe at any time.

Share